EUCTR2009-011128-70-NL进行中（未招募）1 期
A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •1. Written informed consent obtained prior to any screening procedures
- •2. Adult patients with confirmed diagnosis of ACTH-dependant Cushing’s disease as evidenced by all of the following:
- •a. The mean of three 24-hour urine samples collected within 2 weeks = 1.5 x ULN and = 5x ULN (as determined by the central lab of this study)
- •b. Morning plasma ACTH within the normal or above normal range
- •c. Confirmation of pituitary origin of excess ACTH by at least one of the following three:
- •I.History of MRI confirmation of pituitary adenoma (greater than 6 mm) with positive dynamic test (e.g. CRH or high dose dexamethasone suppression test)
- •II.History of inferior petrosal sinus sampling in patients with a tumor less or equal than 6 mm that meet any of the following criteria with either CRH or DDAVP (desmopressin) stimulation:
- •Central to peripheral ACTH ratio = 2 at baseline, or
- •Central to peripheral ACTH ratio = 3 after stimulation by either CRH or DDAVP (desmopressin)
- •III.Prior pituitary surgery with histopathology confirming an ACTH staining adenoma
- •3. Patients with de novo Cushing’s disease can be included only if they are not considered candidates for pituitary surgery (e.g. poor surgical candidates, surgically unapproachable tumors, patients who refuse to have surgical treatment)
- •4. Confirmation that pseudo-Cushing’s is excluded for patients with mUFC = 3 x ULN (local lab analysis is sufficient) by at least 2 of 3 tests being abnormal (low-dose dexamethasone suppression test, dexamethasone-CRH test or late salivary or serum cortisol), unless there is histopathologic evidence for an ACTH staining pituitary tumor.
- •5. Male or female patients aged 18 years or greater
- •6. Karnofsky performance status = 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
- •7. For patients on medical treatment for Cushing’s disease the following washout periods must be completed before screening assessments are performed
- •a. Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
- •b. Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPAR? agonists (rosiglitazone or pioglitazone): 4 weeks
- •c. Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
- •d. Octreotide (immediate release formulation): 1 week
- •e. Progesterone receptor antagonist (mifepristone): 4 weeks
- •8. Patients with a known history of impaired fasting glucose or DM may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the study and adjusted as necessary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •1. Patients who are considered candidates for surgical treatment at the time of study entry
- •2. Patients who have received pituitary irradiation within the last ten years prior to visit 1
- •3. Patients who have had any previous pasireotide treatment
- •4. Patients who have been treated with mitotane during the last 6 months prior to Visit 1
- •5. Patients with compression of the optic chiasm causing any visual field defect that requires surgical intervention
- •6. Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c >8%
- •7. Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >470 ms, hypokalemia, hypomagnesemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
- •8. History of HIV infection, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical history will be reviewed
- •9. Patients with Cushing’s syndrome due to ectopic ACTH secretion
- •10. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
- •11. Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
- •12. Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- •13. Patients who are hypothyroid and have clinical symptoms of hypothyroidism despite adequate replacement therapy
- •14. Patients who have undergone major surgery within 1 month prior to starting the study
- •15. Patients with symptomatic cholelithiasis
- •16. Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits)
- •17. Patients receiving anticoagulants that affect PT or PTT
- •18. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function
- •19. Patients with liver disease such as cirrhosis, chronic active hepatitis B or C, or patients with ALT/AST more than 2 X ULN, serum bilirubin >1.5 X ULN
- •20. Patients with serum creatinine >2.0 X ULN,
- •21. Patients with WBC <3 X 109/L; Hgb 90% < LLN; PLT <100 X 109/L
- •22. Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator or the sponsor’s medical monitor
研究者
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